Food, drugs, devices › Blue Belt Technologies, Inc
Device recall: CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
FDA enforcement event 93620 is a device recall by Blue Belt Technologies, Inc of Pittsburgh, PA, initiated 13 Nov 2023 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Blue Belt Technologies, Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Blue Belt Technologies, Inc, Pittsburgh, PA.
Reason for recall
"Possibility that the user is unable to resolve drill disconnection error messages."
Distribution
"Domestic: Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0708-2024 | CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S | 1859 units | Class II | Ongoing | 17 Jan 2024 |
Context
Other enforcement events for Blue Belt Technologies, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 May 2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing softw | Device | Class II | 1 |
| 7 Sep 2023 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB1029 | Device | Class II | 1 |
All 3 events for Blue Belt Technologies, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Possibility that the user is unable to resolve drill disconnection error messages."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic: Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.